Senior Bioinformatics Scientist, IVD Development

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.

The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum.

Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Be part of a team in the late and final scientific stages of making breakthrough medical diagnostics available for patients. This role will contribute to the late stages of development and validation of Guardant’s industry leading liquid biopsy assays and other products.

You will support the development and validation of these technologies by leading the design and analysis of experiments to validate and characterize medical diagnostics. You will apply and develop new analytical and statistical methods to describe results internally and externally to partners or regulatory agencies.

Expertise in bioinformatics, data analysis, and experimental design will be integral to the strategy for the full team including Operations, Regulatory Affairs, QA, Software Engineering, and others.

Responsibilities:

• Design and defend analytical experiments with clinical samples
• Develop statistical methods and procedures describe and validate Guardant’s technologies
• Write experimental protocols and reports in collaboration with assay development scientists
• Support the increasing scale of running many thousands of samples per year by implementing appropriate QC and validation methods
• Propose and present detailed designs and concise, well-written reports to a cross-functional teams

• PhD-level with 4+ years related industry experience.
• Experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models)
• Ability to develop analyses, models, and reproducible reports with Python or R
• Ability to build reproducible and well-written code or packages for data analysis
• Experience successfully managing requirements and completing cross-functional, scientific projects.
• Preferred experience developing or validating tests or devices in a regulated environment
• Preferred experience troubleshooting, maintaining, or launching of a medical product
• Familiarity with NGS technology and workflows
• Deep interest and active curiosity in improving medical technology and practice

Covid Vaccination Policy:  Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws.  

An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/